Polyphenol Bioavailability From Chocolate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00492713
First received: June 25, 2007
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised that the bioavailability of epicatechin from milk chocolate was reduced compared to dark. The primary outcome measure is to compare plasma polyphenol levels after consumption of 3 chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax for use in future studies.


Condition Intervention
Healthy
Other: dark chocolate
Other: Milk chocolate 1
Other: Milk chocolate 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of the Bioavailability of Polyphenols From Milk and Dark Chocolate

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • AUC plasma polyphenols [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax and Cmax of plasma polyphenols [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Plasma and urinary metabolite identification and quantification [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2007
Study Completion Date: April 2012
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Dark chocolate
Other: dark chocolate
dark chocolate
Active Comparator: 2
Milk chocolate 1
Other: Milk chocolate 1
Milk chocolate 1
Active Comparator: 3
Milk chocolate 2
Other: Milk chocolate 2
Milk chocolate 2

Detailed Description:

Dark chocolate is one of the richest sources of polyphenols, for example, a standard 40g portion of dark chocolate contains 400-800 mg of polyphenols, compared to red wine (170 mg /100ml) or an apple (200 mg/piece). Cocoa polyphenols, most notably the catechins, can exist in both lipid and water-based environments (amphipathic), meaning they can spare both lipophillic and hydrophilic vitamins. There have been a number of human trials conducted using chocolate or cocoa and measuring various endpoints. Most have been conducted with dark chocolate. An article in Nature found that the bioavailability of epicatechin from milk chocolate was substantially reduced compared to dark, and even dark taken with a glass of milk (Serafini et al 2003). The hypothesis was that the milk proteins bind to polyphenols, making them unavailable. Subsequent studies have not been able to reproduce this, but none have been conducted using solid chocolate as the first study, all have been done using a drink matrix, which may completely alter the binding interactions of the polyphenols and protein. Previous bioavailability trials with dark chocolate have shown a 12 fold increase in plasma epicatechin 2 hours after consumption of 80g of chocolate containing 557 mg total polyphenols (137 mg epicatechin) (Rein et al 2000) with a concurrent increase in plasma total antioxidant capacity and a decrease in TBARS. Another study showed an increase in epicatechin 2 hours after administering 25g of chocolate chips containing 220 mg flavanols and procyanidins, with a concurrent increase in prostacyclin/leukotriene ratio and reduction in platelet-related hemostasis (Holt et al 2002).

This study is designed as a blinded, three arm crossover trial. The primary outcome measure is to compare plasma polyphenol levels after consumption of 3 chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax for use in future studies. All volunteers will try all chocolate types with a similar taste & appearance (though milk and dark are likely to still be distinguishable for the volunteer, not the investigator). Subjects will undergo medical screening, anthropometry, physical activity and dietary assessments before randomisation for the order of consumption. Bloods are to be taken as a time course for the next 24 hours, as is urine.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 19 - 45 years, male and female
  • Healthy as determined by the medical questionnaire
  • Normal weight: BMI 19 - 25
  • Having given informed consent

Exclusion Criteria:

  • Intestinal or metabolic diseases/disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
  • Have had a major gastrointestinal surgery.
  • Have a regular consumption of medication.
  • Have an exceptionally high intake of chocolate or similarly high polyphenol foods.
  • Have a high and regular intake of vitamin supplements
  • Have an alcohol intake: > 2 units a day
  • Patient who cannot be expected to comply with treatment.
  • Smoker
  • Having a nut allergy
  • Unwilling to consume chocolate
  • Currently participating or having participated in another clinical trial during the last 3 weeks.
  • Having given blood in the past three weeks
  • More than 3 x 45 min of exercise per week
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492713

Locations
Switzerland
Nestle Research Center
Lausanne, Vaud, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Karen A Cooper, PhD Nestlé
Study Director: Gary Williamson, PhD Nestlé
  More Information

Publications:
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00492713     History of Changes
Other Study ID Numbers: 06.31.MET
Study First Received: June 25, 2007
Last Updated: March 27, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Nestlé:
Bioavailability
Dark Chocolate
Milk Chocolate
Polyphenols

ClinicalTrials.gov processed this record on October 19, 2014